Clot retrieval device

ABSTRACT

The shape memory clot retrieval device can be placed in the vasculature of a patient for retrieving and removing distal clots. The clot retrieval device has an elongated catheter member that can be inserted in the vasculature, with one or more clot retrieval members on the elongated catheter member that are movable between an initial compressed configuration in which the clot retrieval device is inserted into the vasculature and an expanded configuration extending outwardly from the elongated catheter member to trap and hold clots within the vessel. The clot retrieval device typically can be introduced to the desired treatment site in the vasculature through a guiding catheter.

BACKGROUND OF THE INVENTION

1. Field of the Invention:

This invention relates generally to medical instruments for retrievingand withdrawing clots from the vasculature, and more particularlyconcerns a shape memory clot retrieval device having an elongatedcatheter member with at least one clot retrieval member connected to theelongated catheter member that is movable between an initial compressedconfiguration in which the clot retrieval device is inserted into thevasculature and an expanded configuration extending outwardly from theelongated catheter member to trap and hold clots within the vessel.

2. Description of Related Art:

Recently developed interventional procedures have been used to treatdefects in the vasculature which are not easily reached by surgicalprocedures. More particularly, such interventional procedures have beendeveloped to treat defects that are located in small and remote vesselssuch as those within the brain. During such interventional procedures,vasoocclusive devices are typically placed within the vasculature of thehuman body by use of a catheter, either to block the flow of bloodthrough a vessel making up that portion of the vasculature through theformation of an embolus, or to form such an embolus within an aneurysmstemming from the vessel. When an embolus generating vasoocclusivedevice is used to treat an aneurysm, the success of the treatmentgenerally depends upon whether the embolus generating vasoocclusivedevice can migrate out of the aneurysm through the neck of the aneurysm.Migration of the embolus generated out of the aneurysm into the parentvessel poses a danger to the patient, so that it would be desirable toprovide a device for retrieving and withdrawing such an embolus, whetherthe embolus has been created by an embolus generating vasoocclusivedevice or otherwise.

One conventional technique for retrieving deleterious materials such asan embolus from body lumens involves the use of a retrieval catheterhaving a slack net at its distal end that is operated by a pull wire,that may be collapsed to facilitate introduction of the catheter into abody lumen, and that may be opened when necessary to permit capture andretrieval of the deleterious materials. The slack net structure issecured to a flexible loop member which is secured to the pull wire, andthe flexible loop member is formed from resilient materials possessing amemory so that when pull wire is retracted, the loop member will regaina preset circular configuration. However, such a structure is relativelybulky and cumbersome, making the technique difficult to employ in moredistal areas of the vasculature with narrow lumens, such as in thebrain.

A catheter apparatus is also known that employs a shape memory alloystructure as an actuator for a thin shutter door to open and close aradially disposed opening in the catheter for collecting plaque. Whilethis apparatus is suitable for collecting plaque on the inside of ablood vessel, it is not generally effective for retrieving andwithdrawing an embolus that may be loose or free floating within thevasculature. Another known technique uses an adjustable closed wire loopor snare that is manipulated over an object to be retrieved, and in onesuch apparatus, the surgical snare is made from a shape memory materialthat can be trained to remember a specific configuration. However, thesetypes of surgical snares can require great care and dexterity for theiroperation in acquiring an embolus, and an embolus can easily escape, sothat it would be desirable to provide a system for retrieving andwithdrawing an embolus within the vasculature of a patient that can bedeployed in narrow, distal vessels for trapping and holding distal looseor free floating clots. The present invention meets these needs.

SUMMARY OF THE INVENTION

Briefly, and in general terms, the present invention provides for animproved shape memory clot retrieval device that can be placed in thevasculature of a patient for retrieving and removing distal clots. Theclot retrieval device advantageously has an elongated catheter memberthat can be inserted in the vasculature, with one or more clot retrievalmembers on the elongated catheter member that are movable between aninitial compressed configuration in which the clot retrieval device isinserted into the vasculature and an expanded configuration extendingoutwardly from the elongated catheter member to trap and hold clotswithin the vessel. The clot retrieval device typically can be introducedto the desired treatment site in the vasculature through a deliverycatheter.

The invention accordingly provides for an apparatus for removing clotsfrom the vasculature of a patient, comprising an elongated cathetermember, and one or more clot retrieval members connected to theelongated catheter member. The one or more clot retrieval members areadvantageously formed from a shape memory material so that they aremovable upon activation between an initial compressed configuration andan expanded configuration extending outwardly from the elongatedcatheter member to trap and hold clots within the vessel. The elongatedcatheter member is adapted to be placed within a vessel of the patientwhen the one or more clot retrieval members are in the compressedconfiguration, and is adapted to be removed from the vessel when theclot retrieval members are in the expanded configuration, whereby clotstrapped by the clot retrieval members can be withdrawn from the vessel.In a presently preferred aspect, the clot retrieval members are formedfrom a shape memory material, preferably having a glass transitiontemperature (T_(g)) above body temperature, and having a desiredcompressed configuration at a temperature appropriate for introductioninto the body via a catheter, and an expanded configuration with the oneor more clot retrieval members extending outwardly that is assumed uponactivation.

The shape memory material is currently preferably a shape memorypolymer, such as polyurethane, heat shrink tubing such as polyethylene,polyethylene terephthalate (PET) or high density polyethylene (HDPE),although the shape memory material may alternatively be a shape memorymetal such as nickel titanium alloy, such as that available under thetrade name NITINOL, for example, that can be heat treated to have shapememory behavior. As the clot retrieval members are activated by heat,the activated shape memory clot retrieval members open radially andoutwardly to catch and hold clots in the vasculature.

A heat activation member is also preferably provided for heating the oneor more clot retrieval members to cause them to expand radiallyoutwardly from the elongated catheter member. In a presently preferredaspect, the heat activation member typically can be advanced axiallythrough the middle of the elongated catheter member and the one or moreclot retrieval members to be positioned adjacent to the one or more clotretrieval members. The heat activation member currently preferablycomprises an optical fiber, although the heat activation member can alsocomprise a heat pipe, or a device for generating heat by RF energy, orthe like.

In one presently preferred embodiment, the elongated catheter member istubular, and the one or more clot retrieval members comprise a tubularmember formed from a shape memory material having a tubular walldefining a plurality of ridges and valleys. The ridges and valleys aremovable between an initial compressed configuration in which the ridgesand valleys are substantially flattened, to an expanded configurationwherein the ridges extend outwardly from the valleys of the elongatedcatheter member to trap and hold clots within the vessel. The elongatedcatheter member is thus adapted to be placed within a vessel of thepatient when the plurality of ridges and valleys are in the compressed,flattened configuration and removed from the vessel when the ridges andvalleys are in the expanded configuration, whereby clots trapped by theridges and valleys can be withdrawn from the vessel. In a presentlypreferred aspect, the ridges and valleys of the clot retrieval tubularmember are initially compressed axially, radially, or both.

In another presently preferred embodiment, the one or more clotretrieval members comprise a plurality of tab members connected to theelongated catheter member. The plurality of tab members are movablebetween an initial compressed configuration to an expanded configurationextending outwardly from the elongated catheter member to trap and holdclots within the vessel, and the elongated catheter member is adapted tobe placed within a vessel of the patient when the tab members are in thecompressed configuration and removed from the vessel when the tabmembers are in the expanded configuration, whereby clots trapped by thetab members can be withdrawn from the vessel.

In one presently preferred embodiment, the elongated catheter membercomprises an elongated, tubular member, and the one or more clotretrieval members are formed from the tubular wall of the elongatedtubular member, defining a plurality of tab members that are initiallycompressed axially, radially, or both to extend contiguously with thesurface of the tubular wall. In a preferred aspect, the elongatedtubular member and tab members are formed from a shape memory material.

In an alternate preferred embodiment, the elongated catheter membercarries one or more clot retrieval members that can comprise an annularring, preferably formed from a shape memory material, connected to theelongated catheter member, with the annular ring having an initialcompressed configuration in which the annular ring is compressedradially against the surface of the elongated catheter member, and anexpanded configuration in which the annular ring projects outwardly fromthe surface of the elongated catheter member, whereby the extendedannular ring can trap and hold a blood clot.

In another presently preferred alternate embodiment, the elongatedcatheter member carries a plurality of tab members, with each of the tabmembers being connected at one end to the elongated catheter member andhaving a free end, with the tab members having an initial compressedconfiguration in which the tab members are compressed against thesurface of the elongated catheter member and an expanded configurationin which the tab members project outward radially from the surface ofthe elongated catheter member, whereby the extended tab members can trapand hold a blood clot. The tab members can be initially compressedaxially, radially, or both. In a presently preferred aspect, the tabmembers are formed from a shape memory material.

In yet another presently preferred embodiment, the apparatus forremoving clots comprises an elongated catheter member and the clotretrieval member comprises an elongated sheet or ribbon of shape memorymaterial having first and second ends connected to the elongatedcatheter member, with the elongated sheet of shape memory material woundin a helical configuration about the elongated catheter member. Theribbon of shape memory material has an initial compressed configurationin which the ribbon of shape memory material is compressed radiallyagainst the surface of the elongated catheter member and an expandedconfiguration in which the ribbon of shape memory material projectsoutward radially from the surface of the elongated catheter member,whereby the extended ribbon of shape memory material can trap and hold ablood clot.

These and other aspects and advantages of the invention will becomeapparent from the following detailed description and the accompanyingdrawings, which illustrate by way of example the features of theinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional view of a first preferred embodiment of aclot retrieval device according to the present invention, showing theclot retrieval member in a precompressed state;

FIG. 2 is a cross-sectional view of the clot retrieval device of FIG. 1,following compression of the clot retrieval member;

FIG. 3 is a cross-sectional view of the clot retrieval device of FIG. 1,following expansion of the clot retrieval member by heat activation;

FIG. 4 is a side elevational view of a second preferred embodiment of aclot retrieval device according to the present invention, showing theclot retrieval members in a precompressed state;

FIG. 5 is a side elevational view of the clot retrieval device of FIG.4, following compression of the clot retrieval members;

FIG. 6 is a side elevational view of the clot retrieval device of FIG.4, following expansion of the clot retrieval members by heat activation;

FIG. 7 is a side elevational view of a third preferred embodiment of aclot retrieval device according to the present invention, showing theclot retrieval members in an expanded state;

FIG. 8 is a side elevational view of the clot retrieval device of FIG.7, showing the clot retrieval members in a compressed state;

FIG. 9 is a side elevational view of a fourth preferred embodiment of aclot retrieval device according to the present invention, showing theclot retrieval member in an expanded state;

FIG. 10 is a side elevational view of the clot retrieval device of FIG.9, showing the clot retrieval member in a compressed state;

FIG. 11 is a side elevational view of a fifth preferred embodiment of aclot retrieval device according to the present invention, showing theclot retrieval members in an expanded state;

FIG. 12 is an end view of the clot retrieval device of FIG. 11, showingthe clot retrieval members in an expanded state;

FIG. 13 is a side elevational view of the clot retrieval device of FIG.11, showing the clot retrieval members in a compressed state;

FIG. 14 is a side elevational view of a fifth preferred embodiment of aclot retrieval device according to the present invention, showing theclot retrieval member in an expanded state; and

FIG. 15 is a side elevational view of the clot retrieval device of FIG.14, showing the clot retrieval member in a compressed state.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

While one method of treatment of an aneurysm or arterio-venousmalformation can involve creation of an embolus by an embolus generatingvasoocclusive device, the potential migration of such an embolus intothe vasculature of a patient can pose a risk to the patient. Techniqueshave been developed for scavenging such an embolus from the vasculature,but they have generally proved to be difficult to employ in the moredistal, narrow areas of the vasculature, such as in the brain.

As is illustrated in the drawings, the invention is embodied in a clotretrieval apparatus 20 for removing clots from the vasculature of apatient. With reference to FIGS. 1 to 3, in one presently preferredembodiment, the clot retrieval apparatus includes an elongated cathetermember 22, and a clot retrieval portion 23 having one or more clotretrieval members 24 connected to the elongated catheter member. Theclot retrieval members are movable between an initial compressedconfiguration illustrated in FIG. 2, to an expanded configuration,illustrated in FIG. 3, extending outwardly from the elongated cathetermember to trap and hold clots within the vessel. The clot retrievalapparatus is thus adapted to be placed within a vessel of the patientwhen the clot retrieval members are in the compressed configuration, andis adapted to be deployed within the vessel of the patient to move theone or more clot retrieval members to their expanded configuration.Thereafter, the clot retrieval apparatus can be removed from thepatient's vessel, to retrieve and remove any clots that may be trappedby the clot retrieval members.

In a presently preferred aspect of the first embodiment of the clotretrieval apparatus, the elongated catheter member is tubular, and theclot retrieval members are formed as a plurality of ridges 26 andvalleys 28 in the tubular wall 30 of the elongated catheter member. Theplurality of ridges and valleys can be formed in an expanded,precompressed configuration as shown in FIG. 1, and then compressedaxially, radially, or both, under heat and pressure, to the compressedconfiguration shown in FIG. 2, in which the ridges and valleys aresubstantially contiguous and substantially flattened, typically having amaximum compressed outer diameter of about 0.014 inch, to an expandedconfiguration shown in FIG. 3 in which the ridges extend outwardly fromthe elongated catheter member to trap and hold clots within the vessel.The elongated catheter member is adapted to be delivered through aplacement or guiding catheter 32, placed within a vessel of the patientwith the plurality of ridges and valleys in the compressedconfiguration, expanded by heat activation, and removed through theguiding catheter from the vessel when the ridges and valleys are in theexpanded configuration, so that clots trapped by the ridges and valleyscan be withdrawn from the vessel. Typically the ridges are formed in thepre-compression stage to have an expanded outer diameter ranging fromabout 0.014 to about 0.025 inches, so that the guiding catheter willhave an inner diameter greater than this so that the clot retrievalportion can be withdrawn through the guiding catheter in the expandedconfiguration to withdraw clots retrieved from the vasculature. The clotretrieval portion is preferably formed from a shape memory materialhaving a glass transition temperature (T_(g)) above body temperature,with a desired compressed configuration at a temperature appropriate forintroduction into the body via a catheter, and having an expandedconfiguration for trapping and holding clots.

Referring to FIGS. 4, 5 and 6, in an alternate preferred embodimentprovides for a clot retrieval apparatus 40 for removing clots from thevasculature of a patient, having an elongated, tubular catheter member42, and a clot retrieval portion 43. The clot retrieval portion includesa plurality of tab members or fingers 44 cut from the tubular wall 45 ofthe elongated catheter member to have a first end 46 connected to theelongated catheter member, and a free end 48. The clot retrieval membersare movable between an initial compressed configuration illustrated inFIG. 5, and an expanded configuration illustrated in FIG. 6 extendingoutwardly from the elongated catheter member to trap and hold clotswithin the vessel. The elongated catheter member is adapted to bedelivered through a guiding catheter as described above, for placementwithin a vessel of the patient when the tab members are in thecompressed configuration, and the clot retrieval portion and tab membersare dimensions so as to be removable from the vessel through the guidingcatheter when the tab members are in the expanded configuration, suchthat clots trapped by the tab members can be withdrawn from the vessel.The tubular wall of the elongated tubular catheter member and the tabmembers are preferably formed from a shape memory material, and the tabmembers are initially compressed axially, radially, or both to besubstantially flattened to extend substantially contiguously with theexterior surface of the tubular wall of the tubular catheter member.

With reference to FIGS. 7 and 8, in another alternate preferredembodiment, a clot retrieval apparatus 60 is provided for removing clotsfrom the vasculature of a patient, having an elongated, tubular cathetermember 62, and a clot retrieval portion 63 having a plurality of tabmembers or fingers 64 projecting from the tubular wall 65 of theelongated catheter member. The tab members or fingers have a first end66 connected to the elongated catheter member, and a free end 68. Inthis embodiment, the tab members 64 are currently preferably attached tothe elongated, tubular catheter member such as by an adhesive, such ascyanoacrylate adhesive, for example, and are movable between an initialcompressed configuration shown in FIG. 8, to an expanded configurationillustrated in FIG. 7 extending radially outwardly from the elongatedcatheter member to trap and hold clots within the vessel. The elongatedcatheter member is adapted to be delivered through a guiding catheter asdescribed above, to be placed within a vessel of the patient when thetab members are in the compressed configuration. The elongated cathetermember and clot retrieval portion are dimensioned so a to be removablefrom the vessel through the guiding catheter when the tab members are inthe expanded configuration, such that clots trapped by the tab memberscan be withdrawn from the vessel. The tubular wall of the elongatedtubular catheter member and the tab members are preferably formed from ashape memory material, and the tab members are initially compressedaxially, radially, or both to be substantially flattened to extendcontiguously with the exterior surface of the tubular wall of thetubular catheter member.

In another presently preferred alternate embodiment illustrated in FIGS.9 and 10, the invention provides for a clot retrieval apparatus 80 forremoving clots from the vasculature of a patient, having an elongated,tubular catheter member 82, and a clot retrieval portion 83 having anannular ring 84 connected to the elongated catheter member. The annularring can be activated to transform from an initial compressedconfiguration illustrated in FIG. 10 in which the annular ring iscompressed radially against the surface of the elongated cathetermember, to an expanded configuration illustrated in FIG. 9, in which theannular ring projects outwardly from the surface of the elongatedcatheter member, whereby the extended annular ring can trap and hold ablood clot. The annular ring is currently preferably attached to theelongated, tubular catheter member such as by an adhesive, such ascyanoacrylate adhesive, for example, and is advantageously formed from ashape memory material. The annular ring is initially compressed axiallyand radially to be substantially flattened, for insertion through aguiding catheter to the treatment site in the vasculature, and the shapememory material of the annular ring has a desired compressedconfiguration at a temperature appropriate for introduction into thebody via a catheter, and takes on an expanded configuration upon heatactivation, for trapping and holding clots.

A further presently preferred alternate embodiment is illustrated inFIGS. 11, 12 and 13 showing a clot retrieval apparatus 100 for removingclots from the vasculature of a patient. The clot retrieval apparatusincludes an elongated, tubular catheter member 102, and a clot retrievalportion 103 having a plurality of tab members or fingers 104 projectingfrom the tubular wall 105 of the elongated catheter member, and having afirst end 106 connected to the elongated catheter member, and a free end108. In this embodiment, the tab members 104 are currently preferablyattached to the elongated, tubular catheter member in an umbrellaconfiguration such as by an adhesive, such as cyanoacrylate adhesive,for example, and are movable between an initial compressed configurationshown in FIGS. 12 and 13 in which the free ends of the tab members aresubstantially flattened radially against the exterior surface of theelongated catheter member, to an expanded configuration illustrated inFIG. 11, in which the tab members project outward radially from thesurface of the elongated catheter member, whereby the extended tabmembers can trap and hold a blood clot. The elongated catheter member isadapted to be delivered through a guiding catheter as described above,for placement within a vessel of the patient when the tab members are inthe compressed configuration, and the tab members and elongated cathetermember are dimensioned to be removable from the vessel when the tabmembers are in the expanded configuration, so that clots trapped by thetab members can be withdrawn from the vessel. The tubular wall of theelongated tubular catheter member and the tab members are preferablyformed from a shape memory material, and the tab members are initiallycompressed axially, radially, or both to be substantially flattened toextend substantially contiguously with the exterior surface of thetubular wall of the tubular catheter member.

A further presently preferred alternate embodiment is illustrated inFIGS. 14 and 15, illustrating a clot retrieval apparatus 120 forremoving clots from the vasculature of a patient. In this embodiment,the clot retrieval apparatus includes an elongated, tubular cathetermember 122, and a clot retrieval portion 123 formed from an elongatedsheet or ribbon 124 of shape memory material having first and secondends 126 and 128 connected to the elongated catheter member such as byan adhesive, such as cyanoacrylate adhesive, for example. The elongatedsheet of shape memory material is preferably wound in a helicalconfiguration about the elongated catheter member, and has an initialcompressed configuration illustrated in FIG. 15, in which the elongatedsheet of shape memory material is compressed radially against thesurface of the elongated catheter member, and an expanded configurationshown in FIG. 14, in which the elongated sheet of shape memory materialprojects outward radially from the surface of the elongated cathetermember, whereby the extended elongated sheet of shape memory materialcan trap and hold a blood clot.

As is illustrated representatively in FIG. 3, in each of the foregoingembodiments, the shape memory clot retrieval members can advantageouslybe activated to move radially outwardly from a compressed configurationto an expanded configuration by a heat activation member 110 connectedto a remote energy source (not shown) for heating the shape memorymaterial clot retrieval members. The heat activation member is currentlypreferably an optical fiber, although other heat transmission memberssuch as a heat pipe, or a device generating heat by RF energy, forexample, may also be suitable. The heat activation member can beadvanced axially through the middle of the tubular elongated cathetermember to have a heat delivery portion 112 in close proximity adjacentto the clot retrieval members so that they can be activated at thedesired treatment site.

In each of the foregoing embodiments, shape memory material preferablyhas a glass transition temperature (T_(g)) above body temperature, witha desired compressed configuration at a temperature appropriate forintroduction into the body via a catheter, and an expanded configurationextending the one or more clot retrieval members outwardly upon heatactivation. The shape memory material is currently preferably a shapememory polymer, such as polyurethane, heat shrink tubing such aspolyethylene, polyethylene terephthalate (PET), or high densitypolyethylene (HDPE), although the shape memory material mayalternatively be a shape memory metal such as nickel titanium alloy,such as that available under the trade name NITINOL, for example, thatcan be heat treated to have shape memory behavior. In one presentlypreferred embodiment, the shape memory material is a shape memorypolymer distributed by Mitsubishi Heavy Industries, Ltd., that is apolyurethane-based material that undergoes a phase transformation at amanufactured temperature, Tg. After the shape memory polymer iscross-linked, the material is molded into its memory shape. The materialbecomes soft and formable at a temperature above Tg, and can be reshapedinto another configuration by application of pressure to the materialand cooling as the pressure is applied, to a temperature below Tg,fixing the new shape in the material as long as the temperature of thematerial remains below the Tg. When the temperature of the materialagain rises above the Tg, the material will return to its originalmemory shape.

It will be apparent from the foregoing that while particular forms ofthe invention have been illustrated and described, various modificationscan be made of the invention. Accordingly, it is not as by the appendedclaims.

What is claimed is:
 1. An apparatus for removing clots from thevasculature of a patient, comprising a tubular elongated catheter memberhaving a tubular wall and an exterior surface; and at least one clotretrieval member connected to said elongated catheter member, said atleast one clot retrieval member being movable between an initialcompressed configuration to an expanded configuration extendingoutwardly from the elongated catheter member to trap and hold clotswithin the vessel, the elongated catheter member being adapted to beplaced within a vessel of the patient when the at least one clotretrieval members is in the compressed configuration and removed fromthe vessel when the clot retrieval member is in the expandedconfiguration, whereby clots trapped by the clot retrieval member can bewithdrawn from the vessel, said at least one clot retrieval membercomprising a plurality of ridges and valleys defined in said tubularwall, said plurality of ridges and valleys being movable between aninitial compressed configuration in which said ridges and valleys aresubstantially contiguous with the external surface of the elongatedcatheter member, and an expanded configuration wherein said ridgesextend outwardly from the elongated catheter member to trap and holdclots within the vessel, the elongated catheter member being adapted tobe placed within a vessel of the patient when the plurality of ridgesand valleys are in the compressed configuration and removed from thevessel when the ridges and valleys are in the expanded configuration,whereby clots trapped by the ridges and valleys can be withdrawn fromthe vessel, and wherein said ridges and valleys are formed from a shapememory material.
 2. The apparatus of claim 1, wherein said plurality ofridges and valleys are compressed axially and radially in saidcompressed configuration.
 3. The apparatus of claim 1, wherein saidshape memory material having a glass transition temperature (T_(g))above body temperature.
 4. The apparatus of claim 1, wherein said shapememory material has a desired compressed configuration at a temperatureappropriate for introduction into the body via a catheter, and afterheat activation after placement in the body, will take on expandedconfiguration for trapping and holding clots.
 5. The apparatus of claim1, wherein said shape memory material is selected from the groupconsisting of polyurethane, polyethylene, polyethylene terephthalate,and high density polyethylene.
 6. The apparatus of claim 1, wherein saidshape memory material comprises a nickel titanium alloy that can be heattreated to have shape memory behavior.
 7. The apparatus of claim 1,further comprising a heat activation member that can be advanced axiallythrough said elongated catheter member and said at least one clotretrieval member for heating said at least one clot retrieval member tocause said at least one clot retrieval member to move from said firstcompressed configuration to said second expanded configuration.
 8. Theapparatus of claim 7, wherein said heat activation member comprises afiber optic member.
 9. The apparatus of claim 7, wherein said heatactivation member comprises a heat pipe.
 10. The apparatus of claim 7,wherein said heat activation member comprises a device for generatingheat by RF energy.